Trial record 3 of 3 for:    melatonin and osteoporosis

Treatment of Osteopenia With Melatonin (MelaOst)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01690000
First received: June 28, 2012
Last updated: June 3, 2014
Last verified: April 2013
  Purpose

The aim of the study is to assess the effect of melatonin treatment in patients with osteopenia on BMD, muscle function, quality of life and calcium homeostasis.


Condition Intervention
Osteoporosis
Drug: Melatonin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Osteopenia With Melatonin: Effects on BMD, Muscle Strength and Quality of Life

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Changes in bone mineral density (BMD) [ Time Frame: baseline and end of study (after 12 months) ] [ Designated as safety issue: No ]
    Effects of melatonin on BMD will be assessed through DXA-scans


Secondary Outcome Measures:
  • Quality of life and sleep [ Time Frame: At baseline and end of study (after 12 months) ] [ Designated as safety issue: No ]
    Quality of life and sleep will be assessed through SF36v2 questionaire, WHO-5 Well being index, and quality of sleep through Pittsburgh Sleep Quality Questionaire.

  • Changes in calcium homeostasis [ Time Frame: baseline, after 3, 6, 9 months, and end of study (after 12 months) ] [ Designated as safety issue: No ]
    Calcium homeostasis will be analyzed through blood and urines samples

  • Effect on muscle and balance function [ Time Frame: Baseline and end of study (after 12 months) ] [ Designated as safety issue: No ]
    As safety parameters, balance and muscle function be performed using a dynamometer and a stadiometer (Meititur Ltd, Finland)

  • Glucosehomeostasis [ Time Frame: baseline, 3,6, 9, and 12 months ] [ Designated as safety issue: No ]
    Changes in glucose levels and HbA1c due to study drug


Enrollment: 82
Study Start Date: November 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Melatonin1
1 mg melatonin nightly
Drug: Melatonin
1 or 3 mg of melatonin PO each night for 12 months
Active Comparator: Melatonin3
3 mg melatonin given nightly
Drug: Melatonin
1 or 3 mg of melatonin PO each night for 12 months
Active Comparator: Placebo
Identical placebo given nightly
Drug: Melatonin
1 or 3 mg of melatonin PO each night for 12 months

Detailed Description:

Background: Melatonin is known for its regulation of circadian rhythm. The production falls with age, which explains why elderly may have disturbed sleep patterns. Laboratory study and animal experimental studies suggests that melatonin also may protect against bone loss through increased osteoblast- and inhibited osteoclast activity. However, so far human studies have not been performed.

Design and patients: Double blinded randomised controlled study. Eighty post-menopausal women (aged 55-75) with osteopenia are randomized to receive 1mg, 3mg or placebo (daily - at night time) for 12 months.

Methods and results: Effects of melatonin on BMD, bone- structure and mass will be assessed through DXA-scans, pQCT, and QCT. Quality of life, sleep, and activity level will be assessed though questionnaires. Calcium homeostasis will be analyzed through blood and urines samples. As safety parameters, balance and muscle function will also be performed.

Conclusion: Expected improvements in BMD, quality of life and sleep.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopausal women between 55 and 75 years.
  • Osteopenia verified by DXA-scans of total hip or lumbar spine (t-score between -1 and -2.5)
  • Written informed consent after oral and written information

Exclusion Criteria:

  • Severely impaired renal function (plasma creatinine >60 eGFR ml/l).
  • Severely impaired hepatic function (Plasma alanine aminotransferase (ALAT) and/or alkaline phosphatase more the doubled compared to upper limit of reference value).
  • Coagulation factors PP <0.6
  • Hypercalcemia (p-ion calcium > 1.32 nmol/l)
  • Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy).
  • Diseases affecting the calcium homeostasis including untreated thyroid diseases.
  • Regular use of medicine affecting the calcium homeostasis; including diuretics, lithium, antiepileptica, glucosteroids.
  • SSRI-product with fluvoxamin.
  • Treatment with carbamazepin
  • Treatment with rifampicin
  • Severe malabsorption syndrome including gastric or intestinal resection.
  • Alcohol or drug abuse.
  • Smokers
  • Major medical or social problems that will be likely to preclude participation for one year.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690000

Locations
Denmark
Osteoporoseklinikken, dept of Endocrinology and Internal Medicine (MEA)
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Anne Kristine Amstrup, MD Osteoporoseklinikken, Dept. of Endocrinology and Internal Medicine (MEA) Aarhus University Hospital, Tage-Hansens Gade 2, AArhus, DEnmark
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01690000     History of Changes
Other Study ID Numbers: 2011-AKA
Study First Received: June 28, 2012
Last Updated: June 3, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Osteoporosis
Melatonin
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014